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CompletedNCT01677715Updated Oct 15, 2012

Study of Yili Mei Yi Tian Active Lactobacillus Drink to Improve Immunity and Digestive System

An interventional study of Yili "Mei Yi Tian" active lactobacillus drink and recombined milk drink contains no lactobacillus in Immunization, Human Influenza and Common Cold, sponsored by Inner Mongolia Yili Industrial Group Co., Ltd. Completed at 2 sites in China. Open to participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-15.

Sponsored by Inner Mongolia Yili Industrial Group Co., Ltd · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
01

Study summary

Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal

02

Conditions studied

  • Immunization
  • Human Influenza
  • Common Cold
  • Constipation
  • Dyspepsia
  • Flatulence
  • Abdominal Pain
03

In context

Common Cold

180 studies on the registry are indexed under Common Cold; 22 are open to participants now.

This study's enrollment of 240 is above the median of 167 across 151 interventional studies indexed under Common Cold.

Browse Common Cold studies →

Lead sponsor

Inner Mongolia Yili Industrial Group Co., Ltd is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 25 to 45 years sub-health white-collars, catch cold for 4 to 6 times in last year, with low immunity;
  • Non-specific and/or moderate constipation;
  • Irregular or occasional gastrointestinal disorders (flatulence, gurgling, feeling heavy after eating, abdominal pain);
  • Slow transit or irregular bowels movements (abnormal feces solidity, bowel movements decreased, e.g. every 2-3 days or less than 3 times per week);
  • Able to understand the nature and purpose of the study including potential risks and side effects;
  • Willing to consent to study participation and to comply with study requirements

Exclusion criteria

Exclusion Criteria:

  • Diagnosed as immunity-low associated with chronic disease;
  • Diagnosed as chronic constipation;
  • Treated gastrointestinal symptoms;
  • Currently suffering from diarrhea;
  • Suffering from rhinitis chronic, laryngitis, labored breathing that similar to flu symptoms. Such as chronic allergic rhinitis, asthma, COPD;
  • Treatment by analgesic such as aspirin and paracetamol;
  • Had laxatives or other remedies to promote digestion 2 weeks prior to the study start;
  • Consuming dairy products or supplements containing pro/pre-biotic 10 days prior to the study start;
  • Long-term use of any prescription or OTC medication that inhibit or prevent flu symptoms, including but not limited to, antihistamine, pectoral, high doses of vitamin C;
  • Recent use (within 3 months of screening) of any prescription or OTC medication that significantly affects immune response, such as antibiotic;
  • Recent inoculation (within 6 months of screening) of influenza vaccine, or other vaccine in 15 days;
  • History of alcohol, drug, or medication abuse;
  • Pregnant or breastfeeding women;
  • Participation in another study with any investigational product within 3 months of screening
  • Any comorbidity that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
240 participants (actual)

Study arms

  • Active comparator
    Yili "Mei Yi Tian" lactobacillus drink

    100ml of Yili "Mei Yi Tian" active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention

    Dietary Supplement: Yili "Mei Yi Tian" active lactobacillus drink

  • Placebo comparator
    recombined milk drink contains no lactobacillus

    100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention

    Dietary Supplement: recombined milk drink contains no lactobacillus

Interventions

  • Dietary supplementYili "Mei Yi Tian" active lactobacillus drink

    100ml of Yili "Mei Yi Tian" active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention

  • Dietary supplementrecombined milk drink contains no lactobacillus

    100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention

06

What researchers measure

Primary outcomes

  1. Change in constipation condition

    Time frame: Baseline & 3 months

  2. Assess severity of flu symptoms

    Time frame: 3 months

Secondary outcomes

  1. Change in immune markers such as antibodies and interleukins

    Time frame: Baseline & 3 months

  2. Change in gut resident flora

    Time frame: Baseline & 3 months

07

Study locations

2 sites
  • NanMoFang Community Health Service Center
    ChaoYang District, Beijing, China
  • Shanghai Municipal Food and Drug Administration Baoshan Office
    Baoshan District, Shanghai, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01677715
Lead sponsor
Inner Mongolia Yili Industrial Group Co., Ltd
Responsible party
Sponsor
First posted
Sep 3, 2012
Start date
Aug 2011
Primary completion
Nov 2011
Completion
Mar 2012
Last update
Oct 15, 2012

Study contacts

Ying An, Ph.D
study director · Inner Mongolia Hilo Industrial Group Co., Ltd
Leiming Xu
principal investigator · Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Digestive system Dept.
Gengru Jiang
principal investigator · Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Kidney Dept.
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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